Japan s responses to REACH and Chemicals Management Policy

Transcription

1 EU-India Environment Forum Mumbai, 17 September 2008 Japan s responses to REACH and Chemicals Management Policy Eisaku TODA Director, Chemicals Evaluation Office Ministry of the Environment, Japan

2 Japan s responses to REACH From trade and industry perspective Commenting on REACH text, RIP guidance, implementation, etc. (Pre-)registration Information exchange through the supply chain From chemicals management perspective Share the same goal: WSSD 2020 target Review of the Chemical Substances Control Law Co-operation and harminisation through SAICM, OECD, etc.

3 Commenting on REACH text submitted by the Government of Japan on 10 July 2003 In response to the Internet Consultation While appreciating EU attitude to protect the human health and the environment, expressed concern on its effects on trade and workability. Submitted specific comments from the viewpoint of: Avoidance of excessive burden to companies Ensuring equal treatment for non-eu companies Ensuring REACH s consistency with international arrangements Ensuring transparency and equality in REACH and its application Also expressed these concerns through diplomatic and other channels.

4 Commenting and clarifications on REACH Implementation The Government of Japan and industry associations (e.g. Japan Chemical Industry Association) commented and sought clarification on REACH implementation through: Japan-EU Regulatory Policy Dialogue WTO/TBT Committee etc The specific issues include: Registration of monomers Provisions for the Only Representatives

5 Some uncertainties already clarified Where are the boundaries between substances, preparations and articles? Explained in RIP 3.8 Guidance Can a manufacturer in the upstream of non-eu supply chain nominate an Only Representative? Yes Can a non-eu distributor nominate an Only Representative? No If the same person/company is nominated as an Only Representative for the same substance by more than one companies, is the tonnage aggregated? No (interpretation corrected)

6 Some uncertainties yet to be clarified Can an Only Representative (OR) nominate a Third-Party Representative? Should a non-eu exporter of preparation provide the downstream users with registration information (eg the name of OR) for ingredient substances (whereas the full ingredient information regarded as CBI)? How can an OR know all the downstream users? If the exemption list is amended, what is the schedule for (pre)registration for the substances that are removed from the exemption list? The SVHC threshold in articles is calculated as percentage of total weight of the article, but what does the objection of some member countries mean? What is the schedule for identifying SVHCs (in addition to the 16 substances)?

7 Raising awareness and facilitating company responses to REACH Ministry of the Environment organised a REACH Symposium in March 2007, and published a pamphlet on REACH Ministry of Economy, Trade and Industry held 22 seminars all over Japan in FY 2007, and published a guidance manual for small and medium sized enterprises. Japan Chemical Industry Association established a REACH Task Force and started consultation services Several other industry association provide similar services Many consultancies provide advice to companies

8 Japan Network for Strategic Response to International Chemicals Management Established in July 2007 Information exchange network to co-operatively respond to international trend in chemicals regulation such as REACH Operates an informative website, mail magazines, electronic bulletin board, seminars 11 organizations form the management board Asahi Kasei Co Ltd Kao Co Ltd Overseas Environmental Cooperation Center Ministry of the Environment Ministry of Economy, Trade and Industry Ministry of Health, Labor and Welfare Sumitomo Chemicals Co Ltd Institute for Global Environmental Strategies Nissan Co Ltd Fujitsu Co Ltd Mitsui Chemicals Co Ltd

9 Companies responses to REACH Pre-registration and preparation for registration Nomination of Only Representative Company s European subsidiary Consultancy (European and Japanese) Importer Responses to substance information exchange forum (SIEF) Participation in consortia Anti-trust considerations Risk assessment Collection of existing information Test plans and risk assessment Responses to evaluation, authorisation and restriction Information exchange for substances in articles

10 Decision tree for responses to REACH - JCIA guidance - Step 1: your products Is your product exported to Europe? Y Is it an article? N Is it a mixture that does not involve chemical reaction? Preparation Y What are the ingredients? Substance Substance A B C N N Does any downstream user export products that use your product? Is it a polymer? Y Polymer N N What are the ingredients for the polymer? Substance Substance A B C REACH does not apply to your product Go to Step 2 Substance In principle you need registration and/or information provision for these substances

11 Decision tree for responses to REACH - JCIA guidance - Step 2:Articles Is a the substance released to the environment during the use of the product? N Does the article contain substances of very high concern? N Y Y In principle you need registration for the substance You will need notification and information provision Is the use of substances in the article restricted? N Y REACH does not apply to your product. You cannot export the article to Europe. Step 3:Authorisation Step 4: Restriction Check the authorisation list. Check the restriction list.

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13 An Example: C2C3 (ethylene & propylene) Task Force Japanese petrochemical companies decided to cooperatively register ethylene and propylene rather than leaving it to individual polymer producers or other downstream users (or importers). Members: Mitsui, Mitsubishi, Asahi, Chisso, Idemitsu, Tosoh, Showa Denko, Maruzen, Nippon Oil, Sumitomo Coordinated by Japan Petrochemical Industry Association Member companies contract the same OR (European consultancy) independently through its affiliate in Japan. The OR deals with (pre-)registration and SIEF activities. A European law firm provides legal advice through the OR s affiliate.

14 Existing consortia (Information collected by JCIA, as of May 2008) Aluminium Antimony Beryllium Cadmium Calcium Carbide Chlorine and chlorinated chemicals Cobalt Copper Essential Oils of orange, bitter orange, lemon and grapefruit Ethanol Ethylbenzene Ferro-alloy Fertiliser and related materials (FARM) Flavours and Fragrances Fluorocarbons and sulphur hexafluoride Formaldehyde Formaca Fuel Ether Graphite Gypsum Lead Lubricating greases Magnesium Magnesium minerals Manganese Molybdenum Nickel Paper and Pulp Phenolic Resins Phthalate Precious Metals Selenium Silicon Silicones Sodium hypochlorite Styrene Sulphuric acid Tellurium Tin Tungsten Vanadium Vinyl Chloride Zinc

15 Key Message from SAICM ー WSSD 2020 Goal ー To achieve, by 2020, that chemicals are used and produced in ways that lead to the minimization of significant adverse effects on human health and the environment, using transparent science-based risk assessment procedures and science-based risk management procedures, taking into account the precautionary approach, as set out in principle 15 of the Rio Declaration on Environment and Development

16 European Schedule REACH: of toward Regist rat ion the 2020 goal Jun. 1st, 2007 Preparing est ablishment of European Chemicals Agency Jun. 1st, 2008 Pre- registration of existing chemicals 100t/ y Chemicals which could have longterm impacts on water env. and give high toxicity to aquatic animals. 1t/y CMR chemicals Dec. 1st, 2008 In case that pre- registration are not implemented, it is treated as new chemicals Nov. 30th, 2010 May 31th, 2013 need only hazard assessment need both hazard and risk assessment Reference: REACH in brief May 31th, 2018

17 North American cooperation toward North American Commission for Environmental Cooperation(Canada, U.S. and Mexico): started Sound Management of Chemicals (SMOC)program 2006 Established CEC Strategy toward Leaders Summit (Montebello, Canada): Agreements on the program to achieve the 2020 goals Canada:Categorization and Chemical Management Plan Categorization of 23,000 chemicals completed in 2006 Risk management measures for priority chemicals being established US:Chemical Assessment and Management Plan (ChAMP) Further promote the HPV Challenge Program (more than 1m pounds) Assess 9,000 chemicals produced more than 25,000 pounds (11t) annually and take the necessary measures by Mexico:Established Inventory of Chemical Substances

18 East Asian Tripartite Cooperation - China, Japan and Korea - December 2006 At the TEMM8 (Tripartite Environmental Ministers Meeting) held in Beijing, three ministers agreed to proceed with information exchange regarding policies and regulations on chemicals management March 2007 Working-level Meeting (Hayama, Japan) November st Tripartite Policy Dialogue (Tokyo) September nd Tripartite Policy Dialogue (Seoul) Working on the comparison of GHS classification etc

19 Development of Japanese Chemicals Management Policy 1973 Chemical Substances Control Law (CSCL) enacted Ban on production and use of persistent, bioaccumulative and toxic substances (eg. PCBs) Pre-marketing evaluation of new chemicals 1986 CSCL amended regulation on persistent and toxic (but not bioaccumulative) substances) 1999 PRTR and MSDS Law enacted 2003 CSCL amended introduced regulation based on ecological risk 2005 Japan HPV Challenge Programme 2006 SAICM adopted After 2007: Review of PRTR Law After 2009: Review of CSCL

20 Chemical regulations in Japan Exposure via the Environ- ment Consumer exposure Chemical Substances Control Law Ban on production and use of PBT substances Restriction and labelling of persistent and toxic substances Notification of production of substances of concern Notification and evaluation of new chemicals for PBT properties Chemical Management Law Register of releases and transfer of hazardous substances Material Safety Data Sheet Air Pollution Control Law, Water Pollution Control Law, etc. Environmental Quality Standards to protect human health and the env Regulates the emission, leaching etc. of hazardous substances Pharmaceutical Affairs Law Licensing of production and use of pharmaceuticals, cosmetics, etc. e Food Sanitation Law Standards and labeling for food and food additives. Poisonous and Deleterious Substances Control Law - Regulates production and use of poisonous and deleterious substances - Material safety data sheet - Regulates the disposal of these substances Agricultur- al Chemicals Regulation Law -Evaluation of toxicity, persistence etc. when licensing agricultural chemicals - Labeling -Regulation on the use of agricultural chemicals Law for Controlling Household Products Containing Harmful Substances Occupa- tional Exposure Industrial Safety and Health Law Ban on the production and use of substances harming workers health Authorisation,, labeling and MSDS for potentially harmful substances Evaluation of mutagenicity of new chemicals

21 CSCL: Testing requirements for new chemicals 1-10t 10t & over Ready biodegradability x x Bioaccumulation (Kow or BCF) x 1) x 1) Mammalian 28-day repeated dose oral toxicity x 1) Bacterial reverse mutation x 1) Chromosome aberration in mammalian cell culture x 1) Mammalian chronic toxicity, toxicity to reproduction and offspring, teratogenicity, carcinogenicity, biotransformation (x) 2) and pharmacological effects Algae growth inhibition x 1) Daphnia acute immobilisation x 1) Fish acute toxicity x 1) Avian reproduction toxicity (and mammalian toxicity to reproduction and offspring) (x) 2) 1) For ready biodegradable substances, only ready biodegradability test is needed. However, other tests need to be performed for degradation products. 2) These tests are only needed for non-degradable and bioaccumulative substances.

22 Types of chemicals regulated under CSCL Name Properties Regulation No. of substances Class-I Specified Chemical Substances Class-II Specified Chemical Substances Type-I Monitoring Chemical Substances Type-II and III Monitoring Chemical Substances Persistent, bioaccumulative, and hazardous (long-term human toxicity or ecotoxicity to higher predators. Persistent, hazardous (longterm human toxicity or ecotoxicity to living organisms), with concern for long-term existence in the environment. Persistent and bioaccumulative, but hazardous properties unknown. (Candidates for the Class-I Specified Chems.) Candidates for the Class-II Specified Chems. (Type II on health, type III on environment) Virtual ban on priduction and use Restriction of production and use (limiting production volume, labelling etc) Reporting on production volume Reporting on production volume Type II 876 Type III 61

23 Investigation of existing chemicals Resolution of the Diet in 1973 (when CSCL was originally adopted) the government should assess the safety of existing chemical substances. (Roles of the government and the industry) Collecting data (test) Assessment New Chemicals Industry Government Existing Chemicals Government Government.Number of Existing Chemicals : about 20,000 Number of substances tested and evaluated (as of March 2008) : Degradation & bioaccumulation: 1543 (by METI) Mammalian toxicity to human: 327 (by MHLW) Ecotoxicity: 509 (by MOE) 23

24 Background Japan HPV Challenge Program International programs aimed at existing chemicals Recommendation by the Diet in 2003 when revision of CSCL revision was adopted. Launched in June Aiming at accelerating collection and release of information on existing chemicals through partnership between of government and industry Modeled on US HPV Challenge Program US HPV Challenge Program Two features; 1. Voluntary program under cooperation between the private and public sectors Safety data of high priority (HPV) existing chemicals are collected voluntary by Sponsor companies (private sector). 2. The Collected Information will be publicly available. 24

25 Japan HPV Challenge Program Organic chemicals (except for Polymers) Identify chemical substances based on the CAS number. HPV : over total 1,000 tons per year (in Japan) (Based on METI s survey of import/manufacturing volume of chemical substances in 2001 ) About 650 substances selected as target chemicals Existing chemical substances produced and imported in Japan over 1000 tons No Information so far Information (to be) collected Collecting data through Japan HPV Challenge Program by sponsored comapnise (Core Target) 126 chemicals Collection through international cooperation through the OECD HPV program and US Challenge Program etc (Japan contributes to OECD program as well) 532 chemicals Target of the Japan HPV program 645 chemicals 25

26 Interim assessment report & Current situation of Japan Challenge Program In June 2008, Interim assessment report of Japan Challenge Program was conducted Summary: Although there were some points which need more considerations, the program was evaluated mostly well along the object, that is the Government will disseminate the information to the public in the form that can be easily understood. <Current Situation> Sponsors have been registered for 89 chemicals (all listed materials*:126 materials) by June privates and 3 groups (including 27 consortia) join in the program Collection of safety information on 2 chemicals were finished 26

27 GLP Requirements In principle, test data submitted for pre-manufacture/import evaluation of new chemicals must comply with Good Laboratory Principles (GLP) (Tests conducted by facilities in other countries complying with OECD-GLP principles are accepted) Tests of existing chemicals by government (or sometimes voluntarily by manufacturer/ importer) are also conducted at GLP test facilities MOE, MHLW, METI set up a common operating procedure to certify conformity to GLP principles (documents required, study audits, inspection, etc.) Ministry Role under GLP tests (example) CSCL MOE Ecotoxicity alga, growth inhibition test, daphnia acute immobilization test, and fish, acute toxicity test, etc. MHLW Toxicity repeated dose 28-day toxicity study in rodents, and in vitro mammalian chromosomal aberration test, etc. METI Bioconc./ biodegradability test and bioconcentration Biodegr. 27

28 Review of Chemical Management Policy Schedule of legislative review PRTR Law: To be reviewed 7 years after the entry into force (in 2007) CSCL: To be reviewed 5 years after the entry into force of the 2003 Amendment of CSCL Nov. 2006, Consult the Central Environment Council on the future policy for the environmental chemicals management -> Joint deliberation with the Industrial Structure Council Aug. 2007, Interim report on the review of PRTR Law Jan. 2008, Started the deliberation for CSCL -> Joint deliberation with the Health Science Council and Industrial Structure Council Toward the end of 2008: Council report expected

29 Envisaged points for CSCL review WSSD 2020 Goal recognized as the fundamental goal Management system based on scientific risk assessment for all chemicals <Specific features> Establish risk assessment system and strengthen information collection on exposure and hazard Obligatory reporting of production volume Request for hazard information for priority chemicals Retain the pre-marketing evaluation of new chemicals Screening and risk assessments to be done by the government Strengthen the management of SVHC Information requirements for persistent and bioaccumulative substances etc. International harmonization Essential uses for POPs, Polymer exemption etc

30 Conclusions <Company responses to REACH> Companies feel some uncertainties in responses to REACH Big companies are largely OK, but smaller companies will need to accelerate their responses <Chemical management policy aspect> REACH has much to learn from to move toward the common goal: WSSD 2020 target. Efforts for greater international harmonisation needed.